Cleared Traditional

K890134 - FTK FECAL TRANSPORT KIT

K890134 is the FDA 510(k) clearance for FTK FECAL TRANSPORT KIT by Evergreen Scientific, Inc.. It is a Class 1 Microbiology device (product code LIO) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K890134 · Evergreen Scientific, Inc. · Microbiology device
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Apr 1989
Decision
98d
Days
Class 1
Risk

K890134 is an FDA 510(k) clearance for the FTK FECAL TRANSPORT KIT. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Evergreen Scientific, Inc. (Los Angeles, US). The FDA issued a Cleared decision on April 21, 1989 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Evergreen Scientific, Inc. devices

Submission Details

510(k) Number K890134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1989
Decision Date April 21, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIO Device, Specimen Collection

All 21
Devices cleared under the same product code (LIO) and FDA review panel - the closest regulatory comparables to K890134.
BACTI-SWAB(TM) NPG
K912832 · Remel Co. · Aug 1991
BACTI-SWAB(TM) II
K912831 · Remel Co. · Jul 1991
PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)
K893905 · Diagnostic Products Corp. · Aug 1989
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · Bio-Rad · Nov 1988
PATHFINDER(TM) CHLAMYDIA EIA BRUSH COLLECTION KIT
K881125 · Kallestad Diag, A Div. of Erbamont, Inc. · Mar 1988
NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT
K871860 · Bio-Rad · May 1987